Pain
Conditions
Keywords
Patients who will undergo a general anesthesia for a procedure in short stay
Brief summary
The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.
Interventions
DRUGTramadol per os (Tradonal Odis® orodispersible tablets)
Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
DRUGTramadol IV (Tradonal® IV)
Administration of tramadol IV given in 3 unit dosage of 35 mg
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA I and II female or male patients undergoing wisdom teeth extraction * Aged 18-70 years * Scheduled for ambulatory surgery requiring postoperative pain medication
Exclusion criteria
* Weight less than 70% or more than 130% of ideal body weight * Neurological disorder * Recent use of psycho-active medication, including alcohol * Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's * Use of chronic anti-emetic medication * Use of chronic corticoid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in pain score between groups | In the first hours after anaesthesia and surgery |
Secondary
| Measure | Time frame |
|---|---|
| Difference in side-effects between the groups | In the first hours after anaesthesia and surgery |
Countries
Belgium
Outcome results
None listed